What Purity Specification Is Acceptable for a Therapeutic Peptide API in an ANDA or NDA Submission?
Introduction: Setting a therapeutic peptide API purity specification is one of the most consequential — and most frequently misjudged — […]
Extrapolation of Indications in Biosimilar Approval: Scientific Principles and Regulatory Precedents
Introduction The regulatory framework governing Extrapolation of Indications in Biosimilar Approval is a well-established, science-driven approach that enables a biosimilar
Case Study: PLGA Microsphere Formulation Development for a 3-Month Depot Antipsychotic
PLGA Microsphere Formulation Development — Case Study Redesign :root{ –ink:#101d2b; –paper:#f6f5f1; –panel:#ffffff; –teal:#1b6e71; –teal-dim:#e4eeed; –amber:#b8802e; –amber-dim:#f4e9da; –slate:#57626e; –line:#e1ddd2; –line-dark:#28394a; }
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Bioequivalence Study Bioanalytical Services: Regulatory Requirements and CRO Selection Criteria
Introduction: Bioequivalence study bioanalytical services are the laboratory backbone of every generic drug approval, formulation change, and lifecycle management submission
Nitrosamine Risk in Drug-Drug Combination Products: How Multiple APIs Amplify Formation Risk
Introduction Nitrosamine Risk in Drug-Drug Combination Products has emerged as a significant toxicological challenge because combining multiple active pharmaceutical ingredients
Antisense Oligonucleotide-Peptide Conjugates: Design Strategies for Targeted Tissue Delivery
Introduction Antisense Oligonucleotide-Peptide Conjugates have emerged as an advanced therapeutic platform designed to address the longstanding pharmacokinetic, biodistribution, and intracellular
Case Study: Nitrosamine Leachable Investigation in a Blister-Packaged Oral Solid Dosage Form
Introduction: Nitrosamine leachables in blister packaging have become one of the most closely scrutinized contamination pathways in oral solid dosage
Native Mass Spectrometry for Therapeutic Peptide Characterization: Non-Covalent Interactions and Complex Stoichiometry
Introduction The structural characterization of biomolecular assemblies increasingly depends on Native Mass Spectrometry for Therapeutic Peptide Characterization, as it enables
PLGA Microsphere Scale-Up Services: From Lab Bench to Pilot and GMP Manufacturing
Introduction Professional PLGA Microsphere Scale-Up Services provide the essential engineering, analytical, and manufacturing infrastructure needed to successfully transition complex poly(lactic-co-glycolic
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Nitrosamines from Excipients: How Common Pharmaceutical Excipients Contribute to Nitrosamine Formation Risk
Introduction Nitrosamines from Excipients primarily arise when trace levels of nitrite impurities present in inactive formulation components react with susceptible